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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT00573443
Date of registration: 13/12/2007
Prospective Registration: Yes
Primary sponsor: Avanir Pharmaceuticals
Public title: Safety and Efficacy of AVP-923 in PBA Patients With ALS or MS STAR
Scientific title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy and to Determine the Pharmacokinetics of Two Doses of AVP-923 (Dextromethorphan/Quinidine) in the Treatment of Pseudobulbar Affect (PBA) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS)
Date of first enrolment: December 2007
Target sample size: 326
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00573443
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Argentina Brazil United States
Contacts
Name:     Adrian Hepner, M.D.
Address: 
Telephone:
Email:
Affiliation:  Avanir Pharmaceuticals
Key inclusion & exclusion criteria

Main Inclusion Criteria:

- The patient has a diagnosis of Amyotrophic Lateral Sclerosis (according to El Escorial
Criteria, WFN, 1998) and the time from diagnosis of ALS is not be longer than 30
months, or the patient has a diagnosis of multiple sclerosis or probable multiple
sclerosis (according to McDonald criteria, 2001)

- The patient has a clinical history and clinical relevant symptoms of Pseudobulbar
Affect (PBA)

- CNS-LS score at baseline is 13 or greater

Main Exclusion Criteria:

- Patients with myasthenia gravis

- Any personal history of complete heart block, QTc prolongation, or torsades de pointes

- Any family history of congenital QT interval prolongation syndrome

- Patients with known sensitivity to quinidine, dextromethorphan or opiate drugs
(codeine, etc.)



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All
Health Condition(s) or Problem(s) studied
Pseudobulbar Affect (PBA)
Intervention(s)
Drug: dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg
Drug: dextromethorphan hydrobromide 30 mg and quinidine sulfate 10 mg
Drug: Placebo
Primary Outcome(s)
PBA Episode Rate Ratio (Post/Pre), Regression Adjusted [Time Frame: Baseline to Day 84]
Secondary Outcome(s)
Mean Change From Baseline at Day 84 in Beck Depression Inventory (BDI-II) Total Score [Time Frame: Baseline and Day 84]
Mean Change From Baseline at Day 84 in SF-36 (Short-Form) Health Survey Medical Outcome Score by Category [Time Frame: Baseline and Day 84]
Mean Change From Baseline in CNS-LS Total Score by Visit [Time Frame: Baseline, Day 15, Day 29, Day 57, Day 84]
Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (EE Population) [Time Frame: Baseline to Day 84]
Mean Change From Baseline to Day 84 in Neuropsychiatric Inventory (NPI-Q) Frequency and Severity Score (ITT Population) [Time Frame: Baseline to Day 84]
Mean Change From Baseline to Day 84 in Pain Rating Scale (PRS) of MS Subjects [Time Frame: Baseline, Day 15, Day 29, Day 57, Day 84]
Secondary ID(s)
07-AVR-123
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
INC Research
Ethics review
Results
Results available: Yes
Date Posted: 10/07/2013
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00573443
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